No

Antihemophilic Agent; Blood Product Derivative

Control bleeding in patients with factor IX deficiency (hemophilia B or Christmas disease)

Mononine® contains nondetectable levels of factors II, VII, and X (<0.0025 units per factor IX unit using standard coagulation assays) and is, therefore, NOT INDICATED for replacement therapy of any of these clotting factors

Mononine® is also NOT INDICATED in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors.

C

Known hypersensitivity to mouse protein

Use with caution in patients with liver dysfunction; prepared from pooled human plasma - the risk of viral transmission is not totally eradicated; monitor patients who receive repeated doses twice daily with PTT and level of factor being replaced (eg, IX). Observe closely for signs or symptoms of intravascular coagulation or thrombosis. Caution should be exercised when administering to patients with liver disease, postoperatively, neonates, or patients at risk of thromboembolic phenomena or disseminated intravascular coagulation because of the potential risk of thromboembolic complications.

1% to 10%:

Central nervous system: Fever, headache, chills

Neuromuscular & skeletal: Tingling

Miscellaneous: Following rapid administration: Transient fever

<1%: Flushing, DIC, thrombosis following high dosages because of presence of activated clotting factors, tightness in chest, somnolence, urticaria, nausea, vomiting, tightness in neck

Symptoms of overdose include disseminated intravascular coagulation (DIC)

Increased toxicity: Do not coadminister with aminocaproic acid may increase the risk for thrombosis

When stored at refrigerator temperature, 2°C to 8°C (36°F to 46°F), coagulation factor IX is stable for the period indicated by the expiration date on its label. Avoid freezing which may damage container for the diluent.

Standard diluent: Dose in units/bag

Minimum volume: Use complete vial(s) for entire dose

Comments: Infusion rate should be up to 225 units/minute (2 mL/minute)

Replaces deficient clotting factor IX; concentrate of factor IX; hemophilia B, or Christmas disease, is an X-linked inherited disorder of blood coagulation characterized by insufficient or abnormal synthesis of the clotting protein factor IX. Factor IX is a vitamin K-dependent coagulation factor which is synthesized in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway. Activated factor IX (IXa), in combination with factor VII:C activates factor X to Xa, resulting ultimately in the conversion of prothrombin to thrombin and the formation of a fibrin clot. The infusion of exogenous factor IX to replace the deficiency present in hemophilia B temporarily restores hemostasis. Depending upon the patient's level of biologically active factor IX, clinical symptoms range from moderate skin bruising or excessive hemorrhage after trauma or surgery to spontaneous hemorrhage into joints, muscles, or internal organs including the brain. Severe or recurring hemorrhages can produce death, organ dysfunction, or orthopedic deformity.

Half-life for IX component: 23-31 hours

Children and Adults: Dosage is expressed in units of factor IX activity and must be individualized. I.V. only:

Number of Factor IX Units Required = body weight (in kg) x desired Factor IX level increase (% normal) x 1 unit/kg

For example, for a 100% level a patient who has an actual level of 20%: Number of Factor IX Units needed = 70 kg x 80% x 1 Unit/kg = 5,600 Units

As a general rule, the level of factor IX required for treatment of different conditions is listed below:

Minor Spontaneous Hemorrhage, Prophylaxis:

Desired levels of factor IX for hemostasis: 15% to 25%

Initial loading dose to achieve desired level: <20-30 units/kg

Frequency of dosing: Once; repeated in 24 hours if necessary

Duration of treatment: Once; repeated if necessary

Major Trauma or Surgery:

Desired levels of factor IX for hemostasis: 25% to 50%

Initial loading dose to achieve desired level: <75 units/kg

Frequency of dosing: q18-30h, depending on half-life and measured factor IX levels

Duration of treatment: Up to 10 days, depending upon nature of insult

Solution should be infused at room temperature

I.V. administration only:

Should be infused slowly: The rate of administration should be determined by the response and comfort of the patient; intravenous dosage administration rates of up to 225 units/minute (~2 mL/minute) have been regularly tolerated without incident.

Infuse at a rate not exceeding 2 mL/minute

Levels of factors being replaced (eg, IX), PTT

Average normal factor IX levels are 50% to 150%; patients with severe hemophilia will have levels <1%, often undetectable. Moderate forms of the disease have levels of 1% to 10% while some mild cases may have 11% to 49% of normal factor IX.

In preparation for and following surgery:

Level to prevent spontaneous hemorrhage: 5%

Minimum level for hemostasis following trauma and surgery: 30% to 50%

Severe hemorrhage: >60%

Major surgery: greater than or equal to 50% prior to procedure, 30% to 50% for several days after surgery, and >20% for 10-14 days thereafter

Early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis indicate discontinuation of use of the concentrate and physician should be contacted if these symptoms occur

Factor IX units listed per vial and per lot to lot variation of factor IX